NCT02560688

Phase 1 Study to Evaluate the Safety and Tolerability of DS-1040b IV Infusion With Clopidogrel in Healthy Subjects

A Phase 1, Open-label, 2-period, Fixed-sequence Study to Evaluate the Safety and Tolerability of DS-1040b IV Infusion Coadministered With Clopidogrel in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to test the hypothesis that coadministration of clopidogrel with DS-1040b will be safe and well tolerated. Subjects entering the study will initially receive a single 12 hour infusion of DS-1040b, to generate data on the effect of DS-1040b alone. After a wash-out period (to ensure that no DS-1040b is left in the blood) subjects will receive repeated clopidogrel doses over 5 days to generate data on the effect of clopidogrel alone. On the sixth day subjects will receive both DS-1040b and clopidogrel, and the effects will be compared to when the two treatments were given alone.

Conditions

• Drug Interaction

Interventions

Type	Name	Description
DRUG	DS-1040b	20 mg single 12-hour intravenous infusion
DRUG	Clopidogrel	Clopidogrel (Plavix) administered orally 300 mg loading dose on Day 1 followed by 75 mg daily on Days 2-5

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-09-25
• Last updated: 2018-12-24

Locations

1 site across 1 country: United Kingdom